Dalbavancin Versus Standard Antibiotic Therapy for Catheter-related Bloodstream Infections Due to Staphylococcus Aureus

NCT05117398 | Recruiting Phase 3 DMC

• 2 other identifiers: APHP2207632021-004038-12
• Study Type: interventional
• Target: 406
• Locations: 1 country
• Sites: 2

Brief Summary

The primary objective of the study is to demonstrate, among patients with non-complicated CR-BSIs due to S. aureus, that a single-dose of intravenous (IV) dalbavancin 1500 mg is non-inferior to standard documented antibiotic therapy for 14 days according to national guidelines at DAY 30 (Long follow up visit). As the secondary objectives, the study aims to evaluate according to treatment group:

1. 1.Cure rate at DAY 14 and DAY 90 (EOS);
2. 2.Mortality rate within 90 days of follow-up;
3. 3.Time to negativation of blood cultures;
4. 4.Patient's quality of life;
5. 5.Hospitalization length of stay;
6. 6.Cost-utility analyses;
7. 7.Occurrence of any adverse event (AE and SAE), until Day 90 (EOS).

Conditions

Catheter Bacteremia; Staphylococcus Aureus Infection

Keywords

catheter-related bloodstream infections; Staphylococcus aureus infection

Outcome Measures

Primary Outcomes (1)

• Cure rate

  Clinical cure without relapse, defined by the absence of all the following: * Local and/or general signs of infection: * Relapse of bacteremia to S. aureus - i.e. a bacteremia due to S. aureus occurring after initial negativation of blood cultures (2 vials); * In dalbavancin arm: Any additional antibiotic therapy active on S. aureus received between DAY 0 and DAY 14; * In both arms: Any additional antibiotic therapy active on S. aureus received after DAY 14; i.e. between DAY 14 and DAY 30; * Deep focus infection including endocarditis; * Death from all causes.

  DAY 30

Secondary Outcomes (7)

• Cure rate

  DAY 14;DAY 90 (EOS)

• Mortality rate

  DAY 90

• Bloodstream clearance

  DAY 14

• Patient's quality of life

  BASELINE; DAY 14; DAY 30; DAY 90 (EOS)

• Hospitalization length of stay

  DAY 90

Study Arms (2)

Dalbavancin

EXPERIMENTAL

Dalbavancin (Xydalba®) 1500 mg - One unique dose

Drug: Dalbavancin administration

Standard documented antibiotic therapy for 14 days according to national guidelines.

ACTIVE COMPARATOR

As currently recommended, investigators will be encouraged to use the intravenous route for the entire duration of treatment. However, in order to interfere as little as possible with usual practice in each center, the antimicrobial therapy will be let to the choice of the physician in charge of the patient after a minimum of 7 days of intravenous treatment. During all the duration of the study, in case of worsening of the clinical condition requiring the prescription of antistaphylococcal, the clinician will prescribe additional antibiotherapy according to standard good practice.

Drug: Standard antibiotic therapy

Interventions

Dalbavancin administration DRUG

A single-dose of intraveneuse (IV) administration of dalbavancin of 1500 mg. In case of patients with chronic renal impairment (creatinin clairance \< 30mL/min), a single-dose of IV administration of reduced dalbavancin of 1000 mg.

Also known as: Xydalba® administration

Dalbavancin

Standard antibiotic therapy DRUG

Standard Antibiotic therapy according to national recommendations. During the study, the start of treatment is considered to be the day of inclusion/randomization (even if active antiobiotic treatment was started, less than 72 hours ago according to inclusion criteria).

Also known as: Standard documented antibiotic therapy

Standard documented antibiotic therapy for 14 days according to national guidelines.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged at least 18 years;
• Blood cultures positive for S. aureus, obtained within 72 hours before randomization (the date considered is the date of the sampling, not the results);
• CR-BSI, defined as:
• One positive blood culture AND Local signs of infection at the catheter site; OR
• at least one positive blood culture obtained from the catheter and the peripheral vein; AND
• A differential period between catheter versus peripheral blood culture positivity of at least 2h as recommended; AND
• Same S. aureus isolate (same phenotype) identified from the catheter and the peripheral vein blood cultures; OR
• One positive blood culture; AND
• Strong presumption of catheter-related infection according to clinical opinion.
• Intravascular catheter - implantable venous access device (port-a-cath and Piccline) - removed before randomization;
• Informed consent form date and signed by the patient.

You may not qualify if:

• Polymicrobial infection;
• Dalbavancin resistant strain;
• More than 72 hours of active antibiotic treatment targeting S. aureus (in-vitro susceptibility) administered prior to randomization;
• Patient with known valvulopathy, previous history of endocarditis, or suspicion of infective endocarditis by physician in charge;
• Suspicion of any other deep focus infections, such as arthritis, pneumonia, osteomyelitis, or meningitis, presence of cerebral or peripheral emboli (arterial occlusion);
• Thrombophlebitis;
• Failure to remove any intravascular catheter which was present when first positive blood culture;
• Signs of infection associated with quick SOFA score ≥ 2 at randomization;
• Patients with foreign bodies such as: prosthetic heart valve, endovascular prosthesis, ventriculo-atrial shunt, pacemaker, or an automated implantable cardioverter defibrillator (AICD) device;
• Severe liver disease (Child-Pugh C);
• Severely immunocompromised patients:
• Neutropenia (\< 500 neutrophils/µL) at randomization;
• Hematopoietic stem cell transplantation within the past 6 months or planned during treatment period;
• Solid organ transplant;
• Contraindication to dalbavancin and/or glycopeptide;

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Centre Hospitalier de Perigueux: collaborator
• Advanz Pharma: collaborator
• Nantes University Hospital: collaborator
• Centre National de Référence des staphylocoques: collaborator

Study Sites (2)

Infectious Diseases Department, Raymond-Poincaré Hospital - APHP

Garches, 92380, France

NOT YET RECRUITING

Infectious Diseases Department, CH PERIGUEUX

Périgueux, 24019, France

RECRUITING

MeSH Terms

Conditions

Staphylococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Bernard CASTAN, MD

  CH de Perigueux

  PRINCIPAL INVESTIGATOR

• Aurélien DINH, MD, PhD

  APHP - RAYMOND POINCARE

  STUDY DIRECTOR

Central Study Contacts

Bernard CASTAN, MD

CONTACT

+33 5 53 45 26 00; bernard.castan@ch-perigueux.fr

Aurélien DINH, MD, PhD

CONTACT

+33 1 47 10 44 32; aurelien.dinh@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase III, pragmatic, open-label, non-inferiority, randomized (1:1), multicenter trial, in patients with non-complicated CR-BSI due to S. aureus, with two parallel groups receiving 14 days of active antimicrobial therapy.

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 11, 2021
• Study Start: June 23, 2023
• Primary Completion: September 23, 2025
• Study Completion (Estimated): September 23, 2026
• Last Updated: April 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)